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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION NEUTRACLEAR NEEDLE-FREE CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
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CAREFUSION NEUTRACLEAR NEEDLE-FREE CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number EL-NC1001
Device Problems Fluid/Blood Leak (1250); Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/13/2018
Event Type  malfunction  
Manufacturer Narrative
Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.
 
Event Description
The customer reported that the patient was receiving a 24-hour chemotherapy infusion at 1ml/hr, as well as mivf at 120ml/hr.The rn disconnected the tubing from the patient's central line in order to administer leucovorin.Once the tubing was disconnected the rn noticed that the nutraclear piston was still depressed, causing medications to leak from the central line.The rn clamped the line and performed a sterile valve change prior to administering any other medications.There was no patient harm.
 
Event Description
The customer reported that the patient was receiving a 24-hour chemotherapy infusion at 1ml/hr, as well as mivf at 120ml/hr.The rn disconnected the tubing from the patient's central line in order to administer leucovorin.Once the tubing was disconnected the rn noticed that the nutraclear piston was still depressed, causing medications to leak from the central line.The rn clamped the line and performed a sterile valve change prior to administering any other medications.There was no patient harm.
 
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Brand Name
NEUTRACLEAR NEEDLE-FREE CONNECTOR
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key7683113
MDR Text Key113874782
Report Number9616066-2018-00981
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K171117
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 06/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberEL-NC1001
Device Catalogue NumberEL-NC1001
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CENTRAL LINE, THERAPY DATE: (B)(6) 2018; PRI TUBING
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